CN108568896A - The storage of two component types and mixing apparatus for producing bone cement and associated method - Google Patents

Abstract

The present invention relates to a kind of storage and mixing apparatus for producing bone cement dough by the monomer fluid and finished ground cement of the starting ingredient as bone cement, it includes the bracket for being disposed with the monomer fluid container for accommodating monomer fluid, accommodate the barrel of finished ground cement, it is arranged in bracket and longitudinal movement that can be along bracket and the charging plunger that can be reached from the back side of bracket, and be arranged in barrel and can be longitudinally displaced inside barrel distribution plunger, wherein, bracket front with or can be connect with the back side of barrel, so that the inner space of bracket and the inner space of barrel connect to permeate monomer fluid, the connection is separable, wherein, it is equipped with the first fixing device at the back side of bracket and is equipped with the second fixing device at the back side of barrel, first and second fixing devices are same or like.The invention further relates to a kind of methods for producing bone cement dough, particularly paste polyethyl methacrylate bone cement dough, wherein coming to produce bone cement dough by finished ground cement and monomer fluid by using storage and mixing apparatus.

Description

The storage of two component types and mixing apparatus for producing bone cement and associated method

Technical field

The present invention relates to one kind by monomer fluid and the finished ground cement production of the starting ingredient as bone cement (bone glue mud) The storage of bone cement dough and mixing apparatus.

The invention further relates to one kind for producing bone cement dough, particularly paste PMMA bone cement cream The method of group, wherein producing bone cement dough by finished ground cement and monomer fluid by storing the use with mixing apparatus.

Specifically a kind of equipment, the equipment store polymethyl to subject of the present invention for separated (individually) The finished ground cement and monomer fluid of sour methacrylate bone cement mix with monomer fluid finished ground cement so as to then to produce bone water The bone cement dough of mud dough and distributive mixing.The bone cement dough produced using the equipment is used in particular for the strong of the centrum of fracture Change, that is, is used for vertebroplasty.Storage according to the present invention and mixing apparatus are a kind of cementing systems pre-installed completely (cementing system)。

Background technology

Polymethyl methacrylate (PMMA) bone cement starts sex work (Charnley, J. based on look into Mr. Enbrel： The Anchorage of the femoral head prosthesis of the shaft of the femur (diaphysis of femur Femoral head prosthesis anchoring) .J.Bone Joint Surg.42 (1960) 28-30.).Conventional polymethyl methacrylate bone (K.-D.K ü hn are made by powdery components and liquid monomer component in cement (PMMA bone cements):Knochenzemente für die Endoprothetik:Ein aktueller Vergleich der physikalischen und chemischen Eigenschaften handelsüblicher PMMA-Zemente.Springer-Verlag Berlin Heidelberg New York,2001).Also referred to as the powdery components of finished ground cement or bone cement powder include one or more polymer, no Radioparent object and initiator dibenzoyl peroxide, the polymer matrix is in methyl methacrylate and comonomer such as benzene second Alkene, methyl acrylate or similar monomer are generated by polymerisation, preferably suspension polymerization.In powdery components and monomer The mixing periods of component, the expansion of polymer in methyl methacrylate in powdery components generate dough, the dough energy quilt Plastic Forming and be actual bone cement.In the mixing periods of powdery components and monomer component, activator (N, N- dimethyl-p- Toluidines) it is reacted with dibenzoyl peroxide and is formed simultaneously free radical.The free radical being consequently formed causes methyl methacrylate Raolical polymerizable.When carrying out the polymerisation of methyl methacrylate, the viscosity of cement dough increases until cement Until dough solidifies.

A variety of special PMMA bone cements have been researched and developed to handle the extruding fracture (impression of centrum fracture).These bone cements are characterized in that they include the radiopaque object of higher number, such as zirconium dioxide and sulphur Sour barium.This is to be conducive to the continuous monitoring spread out by fluoroscopy to bone cement dough in the vertebra of fracture. Convex plasty is the method for being most commonly used for strengthening the centrum of fracture at present after vertebroplasty and cone.Currently, mixing It is common that hand mix cement component, which is under the background, in beaker or simple mixing apparatus.

PMMA bone cements can by by scraper plate in mixing beaker appropriate blended cement powder and by monomer fluid It is mixed.This can cause bubble to be closed in bone cement dough, this may generate the mechanical performance of cured bone cement negative Face is rung.

The a large amount of vacuum impregnating cement system for preventing from occurring air inclusion in bone cement dough has been proposed, In, it will be listed below for exemplary purposes herein：US 6,033,105 A、US 5,624,184 A、US 4,671, 263 A、US 4,973,168 A、US 5,100,241 A、WO 99/67015 A1、EP 1020 167 A2、US 5,586, 821 A、EP 1 016 452 A2、DE 36 40 279 A1、WO 94/26403 A1、EP 1 005 901 A2、EP 1 886 647 A1、US 5,344,232 A。

A kind of thixotroping bone cement for cone vertebroplasty is learnt by 2 730 296 A2 of EP, wherein can be by a variety of The use of additive generates thixotropy.

Both wherein finished ground cement and monomer fluid has been packaged in the separated compartment of mixing apparatus and only The cementing system being just mixed with each other in cementing system before application cement is the development of cementing technology.The closing The hybrid system pre-installed completely pass through 0 692 229 10 2,009 031 178 B3, US 5,997,544 of A1, DE of EP A, US 6,709,149 B1, DE 698 12 726 T2, EP 0 796 653 A2 and US 5,588,745 A propose.

10 2,009 031 178 B3 of patent DE disclose a kind of storage as complete prepackage mixing apparatus and mixing is set It is standby, wherein the starting ingredient generated needed for bone cement dough already stored in the storage and mixing apparatus and can store up It deposits and is combined and mixed in mixing apparatus.Storage and mixing apparatus include distributing column for closing the two-part of cement barrel Plug.The combination of breathable disinfection plunger and not breathable sealed plunger is used in this context.Containing vacuum mixed stocker This principle of system is in the closing cementing system for being made by Heraeus Medical GmbH and being sold Implement in PRO.

After mixing finished ground cement with liquid monomer component, PMMA bone cement is with the shape of cement dough Formula is applied under their uncured lotion state.If mixing apparatus is used for powder-cement liquid, cement dough position In barrel.Cement dough is extruded by distributing the movement of plunger from the barrel.Distributing plunger usually has in 30mm Therefore diameter between 40mm simultaneously has the 7.0cm engaged with the push rod of extrusion equipment in extrusion on the outside²Extremely 12.5cm²Surface area.The movement for distributing plunger is realized by being also referred to as the mechanical extrusion equipment of the manual operation of spreader. The manual extrusion equipment generally reaches extrusion force in the range of about 1.5kN to 3.5kN.

By the liquid monomer component and the conventional PMMA bones that are grouped as of the finished ground cement group that separately stores as starting ingredient The application of cement, which is included in, mixes both starting ingredients and will be by by the extrusion equipment of manual operation in cementing system This cement formed squeezes out.These easy mechanical extrusion equipments are in particular with by the tilt lever activated manually for extrusion The clamping bar of bar driving.The extrusion equipment of manual actuation is subjected to the test of many decades in the whole world and is therefore currently existing skill Art.The extrusion equipment is advantageous in that medical user is (loose to bone structure by the hand-power to be spent to bone cement dough Matter bone) in osmotic resistance feel.

The use of hitherto known all complete prepackage mixing apparatus requires medical user successively to equipment with pre- Graded executes multiple job steps, until mixed bone cement dough is ready to and can be applied.Job step it is any Obscure the failure that can all cause mixing apparatus and therefore leads to the interference in surgical operation.Therefore the high cost of medical user is needed It trains to prevent user's error.

00/35506 A1 of WO propose a kind of equipment, wherein PMMA bone cement powder is stored in In barrel, therefore finished ground cement occupies the entire volume of barrel, and the volume etc. in the gap between the particle of finished ground cement In the volume of the required monomer fluid when producing bone cement dough using the finished ground cement stored in barrel.The equipment Design be appropriate so that the effect of vacuum causes monomer fluid to be supplied in barrel from top, therefore for this purpose, true Sky is applied to the vacuum coupling on the bottom side of barrel.Therefore, monomer fluid is sucked by finished ground cement, therefore is present in Air in the gap of cement granules is substituted by monomer fluid.This is not related to by means of blender to the cement dough that is formed in this way Carry out mechanical mixture.

The shortcomings that system is due to monomer fluid and the finished ground cement that expands rapidly cannot utilize the equipment to mix, because After entering finished ground cement in monomer fluid, the finished ground cement particle expanded rapidly forms about 1 to 2 centimetres of gel screen Barrier, and monomer fluid is interfered to migrate across entire finished ground cement.Moreover, a kind of phenomenon, i.e. cement powder is presented in traditional cements powder Last particle is only poorly soaked by methyl methacrylate due to the difference of surface energy.As a result, methyl methacrylate is only It penetrates slowly into finished ground cement.Moreover, can not rule out the monomer fluid for being exposed to vacuum action in its complete infiltration cement It is sucked out by vacuum coupling after powder.In this case, there is no sufficient amount for by means of free radical polymerization React that cured monomer fluid is available and/or the blending ratio of bone cement and therefore its consistency is inadvertently changed.And And, however, a problem that sinking into the air between finished ground cement particle will be replaced by advancing to the monomer fluid of bottom from top, Because the air with proportion more lower than monomer fluid tends to migrate upwards in finished ground cement, rather than connects along vacuum The direction for connecing device migrates downward under gravity.

Have in 7.0cm in the outer plunger side that the push rod with extrusion equipment engages wherein distributing plunger with barrel-² To 12.5cm²In the range of total surface area-associated in the case of high viscosity paste bone cement, these equipment can be basic It cannot or only can be just manually actuated when spending prodigious power.This bone cement dough to be squeezed out flow resistance due to squeeze The distribution opening that goes out and/or increase due to static mixer-bone cement dough is distributed via hose or trochar wherein for this Backbone application in it is very common-in the case of it is more true.This application energetically is for the medical user in operating room It is unreasonable.

In adhesive and sealant industry, electronic extrusion equipment is also well known.The equipment can utilize one or Multiple rechargeable batteries drive by stationary power source.The equipment can squeeze out especially thick lotion, because in some cases Their extrusion force is very big down.However, use a advantage for motor is that these motors include nonferrous metal and are Expensive commodity.Since the regions OR need to keep sterile, the equipment is needed to carry out cumbersome disinfection or possibly even be needed more It changes.The presence of electric wiring may interfere with locomotivity of the user in OR.

Moreover, also proposed pneumatic equipment.The equipment need static or movable compressed air connection (US 2,446, 20 2,005 010 206 U1 of 501A, DE).This makes the compressed-air hose for needing may interfere with the locomotivity of user.

Alternatively, can also use compressed air barrel to provide compressed gas.Such equipment is proposed thus, wherein The supply of compressed gas is controlled by valve, and in addition, the flow (US 2004/ of viscoid is controlled by the second valve 6,935,541 B1 of 0074927 A1, US).In such devices, gas barrel is integrated in a device.It is connect with compressed air Or these systems comprising compressed gas barrel are needed always there are compressed gas source, these are in the case of no compressed gas source System cannot use.

In cone vertebroplasty, by the application of x-ray program field monitoring bone cement.Application for cone vertebroplasty Equipment usually has the hose being inserted into them, can apply bone cement through the end of the hose to allow user in the model of x-ray It works except enclosing.For this purpose, trochar or sleeve can also be disposed on hose.Such as by 7,112,205 B2, US 8 of US, 038,682 B2、US 8,308,731 B2、DE 10 2005 045 227 A1、EP 1 074 231 B1、EP 1 596 736 2008/097855 A2 of B1, US 9,005,209 B2 and WO knows the system.

Alternatively, other facilities can be used to keep user far from x-ray, such as in 6,676,663 B2, US 7 of document US, 008,433 B2, US 8,348,494 B2, EP1 464 292 B1, EP 1 614 403 B1, US 2008/319445 A9 and Facility described in 2008/038322 A2 of WO.

Know that a kind of bone cement for vertebroplasty for applying bone cement is applied by 2008/0086143 A1 of US Add device comprising hose, trochar and mixer.The bone cement applicator includes two barrels arranged next to one another, is risen Beginning component is also stored in the barrel.Bone cement applicator is just using preceding assembled.The type for cone at In the bone cement applicator of shape art, applied on the starting ingredient of bone cement by the extrusion equipment for promoting the distribution plunger in barrel Plus-pressure, and the pressure is used for that starting ingredient is discharged from barrel and through hose.In this context, starting ingredient usually exists first It is mixed in the static mixer of upstream.As a result, bone cement applicator be used as (barrel mixes with the component on the boundary of bone cement stream The shell and hose of device) flexible deformation occurs.When the propulsion for distributing plunger stops, the elastic force of the component causes the portion The volume contraction of part so that bone cement continues on through hose and/or the application opening of trochar is left.This may cause operating room or The pollution of user with bone cement inadvertently applies excessive bone cement.Moreover, when the volume flow of bone cement dough When starting again at, need to establish pressure in bone cement first so that bone cement leaves through applying opening.This is delayed again can be real Border since its apply bone cement distribution plunger propulsion after time point, this is also undesirable.Due to bone Cement dough and starting ingredient are very viscous, especially using paste starting ingredient, so all these effects It significantly protrudes relatively.This can be offset by the use of thick and heavy and expensive metal shell elements.The component needs make It further uses or needs to recycle with prodigious energy with cleaning or sterilizing later.Moreover, residual starting ingredient may Release and possible contaminated operation room (OR) when barrel is removed.

8,544,683 B2 of US disclose a kind of barrel system, are suitable for a small amount of main starting ingredient of mixing.The barrel system Also there is the second smaller barrel for being arranged therein other than barrel, wherein the distribution plunger in the smaller barrel also together with compared with The propulsion of distribution plunger in big barrel is driven by joint coupling elements together.However, the system is unsuitable for mixing PMMA bone water The sticky paste starting ingredient of mud.

Invention content

Therefore, the purpose of the present invention overcomes the shortcomings that prior art.Specifically, it is an object of the invention to research and develop one kind Storage and mixing apparatus and method, both of which are very suitable for mixing and subsequent distribution and are preferably further adapted to store up Deposit the starting ingredient finished ground cement and monomer fluid as PMMA bone cement.It is used for moreover, providing one kind The method of production prepackage PMMA cement material cartridge systems, the system are very suitable for mixing and applying PMMA bone cements dough and solve Described problem.The storage and mixing apparatus, and the storage and mixing apparatus should can be driven by conventional extrusion equipment It can should as easily as possible operate.Design is not expensive, to allow storage and mixing apparatus due to hygienic reason only It is disposable.As far as possible mostly or all in mixing, the bone of the process for storing with occurring in mixing apparatus, such as starting ingredient The opening of the distribution of cement dough and container and under applicable circumstances barrel, should be in the job step of quantity minimum as far as possible Occur in rapid and should be automated and preferably only be driven by single driving device as far as possible.

Preferably, it is a kind of for paste multicomponent PMMA bone cement, use to also reside in offer by the present invention There are simple designs simultaneously for using in the simple of cone vertebroplasty and the bone cement applicator manufactured at low cost and one kind And the method for the low storage and mixing apparatus application cement dough of manufacturing cost, once wherein cement flowing stops bone cement dough Just do not continue to flow.Moreover, it should can after the flow disruption of bone cement dough as quickly as possible reuse storage and Mixing apparatus.Ambient enviroment and the use with bone cement dough or starting ingredient, particularly monomer fluid should be excluded as far as possible The pollution at family.

Therefore, specifically, it is a kind of for storing and blended cement powder and monomer liquid it is an object of the invention to research and develop The storage of body and mixing apparatus, wherein the PMMA bone cement generated by mixing starting ingredient is preferably For enhancing the centrum of fracture.Storage and the manipulation of mixing apparatus are simplified to the maximum extent, inaccurate routinely to prevent User's error that the assembling steps that ground carries out are brought.Medical user can later will that will store to take out from packaging with mixing apparatus It connect with extrusion equipment and then activates the facility manually.The storage and mixing apparatus should be ensured that finished ground cement and monomer Safe storage of the liquid in individual compartment so that cement component store and mixing apparatus storage during it is any without Meaning mixing is excluded.The storage and mixing apparatus should allow to sterilize using ethylene oxide gas.It is stored in storage and mixing is set Finished ground cement in standby must can be approached by ethylene oxide.Can by means of at present in OR the manual actuation of common type squeeze Go out equipment to start storage and mixing apparatus so that in storage and mixing apparatus or its component with the cooperation of extrusion equipment shape or by force After lockmaking connects surely, the push rod of extrusion equipment is acted on storage and mixing apparatus and is opened since extrusion equipment is activated Monomer fluid container, and then monomer fluid is transferred in finished ground cement in the case that punch is further movement of.Monomer The mixing of liquid and finished ground cement should occur without the help of the mixer to be moved from external hand.The push rod of extrusion equipment It travels forward and the opening of monomer fluid container can be realized, follow-up monomer is transferred in finished ground cement and cement component is in shape It is mixed while at cement dough.It is important that by distribution plunger designed for suitably distributing the cement dough formed in this way, So that the pressure acted in the use of common manual extrusion equipment on distribution plunger is sufficiently high, so that cement dough can be It is extruded through the plastic flexible pipe that internal diameter is 3mm at least in the distance of 20cm.

Storage and mixing apparatus should can be easily manufactured by plastics and therefore storage and mixing apparatus should be suitble to As disposable product.Should can use so far for for for knee and buttocks TEP (hip joint it is total in Prosthese) cemented PMMA bone cements for the extrusion equipment of conventional manual driving of common type carry out the water of extrusion mixing Mud dough.Bone cement applicator, which is suitably designed, allows the bone cement dough flowed in operating room (OR) not by bone water Mud dough pollutes and/or does not occur the emergent stopping immediately in the case of continuing flowing of bone cement dough.

Preferably, two push rods that the bone cement applicator to be researched and developed should need not be connected to each other and be simultaneously advanced, So that whole equipment will not become than therefore for conventional powders-more conventional mixing of liquid PMMA bone cement Equipment is significantly wider, longer and bigger.Aim at find it is a kind of allow if possible use only one push rod and be applicable in In the case of the cup that is connect with it squeeze out the simple scheme of bone cement dough.

The purpose of the present invention is given birth to by a kind of monomer fluid and finished ground cement for by being used as the starting ingredient of bone cement Storage and the mixing apparatus of bone cement dough are produced to meet, the storage and mixing apparatus include：

A) bracket (container, grafting container) is disposed with monomer fluid container in the bracket, and wherein the monomer fluid container holds Receive monomer fluid, and

B the barrel of finished ground cement) is accommodated, wherein

C the charging plunger) being arranged in bracket, wherein the charging plunger can move along the longitudinal direction of bracket and can It is reached (close, to touch) from the back side (rear side) of bracket, and

D the distribution plunger) being arranged in bracket, wherein the distribution plunger can along the longitudinal direction be shifted in the inside of bracket, Wherein

E) front (front side) of bracket with or can be connect with the back side of barrel so that the inner space of bracket connection barrel Inner space is to penetrate monomer fluid, wherein the connection is dissoluble, and wherein

F the first fixing device on the back side of bracket) is arranged and is arranged on the back side of barrel second fixes dress It sets, first fixing device and second fixing device are identical or similar.

Preferably, the first fixing device and the second fixing device are identical.In this way, both bracket and barrel It can in the same manner be fixed on the same holder such as barrel rifle of extrusion equipment, and therefore bracket and barrel can use same squeeze Go out equipment extrusion.Term " barrel rifle " should be understood as further including caulking gun.It is preferable to use the extrusion equipment of manual actuation or material Cylinder rifle.

According to the present invention, storage and mixing apparatus preferably have the design of two component types.

Therefore, the present invention can preferably provide the on the single holder for being adapted and arranged to be fixed on extrusion equipment One fixing device and the second fixing device.

It is preferable to use PMMA bone cements (PMMA bone cements) to be used as bone cement.Therefore, in the case, Finished ground cement is PMMA finished ground cements.

The present invention be preferably able to will to distribute plunger is arranged to can be from the back of the body of barrel when bracket and barrel are not connected to each other Face reaches.

Preferably, monomer fluid container is the container separated with bracket.

The present invention can also be arranged only on the front of barrel especially as a part for distribution pipe distribution be open with For distributing bone cement dough.In this context, the present invention preferably provides airtight seal part, it can be removed or can beat It opens, to close the distribution opening for finished ground cement particle.In this context, the present invention is preferably designed to make closure member Can axial compressive force application or manual force effect when open.

According to the present invention, storage and mixing apparatus can be arranged on the back side of barrel, particularly barrel distribution There is the closed straight-through portion led in the inner space of barrel, wherein the closed straight-through portion preferably may be used in plunger Fluid permeable formula connection between bracket and barrel is closed in fluid-tight manner when detaching, wherein the closed straight-through portion Particularly preferably include valve, at least two sealed lips or transparent self-sealing septum.

Straight-through portion is designed to that closed effect is, after monomer fluid is fed into barrel, monomer fluid It cannot be left through it on the back side of barrel after bracket is detached with barrel.In this way, it is therefore prevented that there is monomer liquid The pollution of the surgical field of body and/or stain.

In this context, preferably the present invention provides the filter being arranged in closed straight-through portion, especially micropore mistake Filter, its impermeable finished ground cement and permeable monomer fluid.In this way, it can prevent finished ground cement from penetrating into It reacts in closed straight-through portion, wherein with monomer fluid, expand wherein, and therefore prevent from inadvertently closing straight-through Portion.

Moreover, hollow needle or pipe can be arranged in the present invention on the front of bracket, the inside of bracket can pass through the hollow needle Or pipe is connected in a manner of conducting liquid with the inner space of barrel, wherein if bracket is connect with barrel, hollow needle or pipe The interconnecting piece for leading to the permeable monomer fluid in the inner space of barrel is formed together with closed straight-through portion.

This enables the closure member of closed straight-through portion to be opened with simple and reliable fashion by means of hollow needle or pipe, and And the closure member can again be closed in an automatic fashion when middle empty needle or pipe are drawn out from closed straight-through portion.Obviously, multiple Hollow needle or multiple pipes also can be used in this purpose.

The present invention also proposes the arrangement connection plunger on the front of bracket, and it is arranged to can be on the inside edge of bracket Longitudinal direction moves, wherein monomer fluid receptacle is between connection plunger and charging plunger, wherein in connecting plunger It is provided with access and the permeable monomer fluid of the access and gas and can be used to establish and the fluid of the inner space of barrel connects It connects, wherein preferably, by means of connecting movement of the plunger on the direction for the barrel that the front with bracket is connect, the back of the body of barrel The connection of the liquid permeable between the inner space and the inner space of bracket closed straight-through portion or close barrel on face The locking device in portion is openable.

This makes fluidly connecting only when connecting plunger movement between the inner space of barrel and the inner space of bracket It just disconnects, or so that storage and the design of mixing apparatus are more easily and simpler.Due to movable connection plunger, barrel can be prevented Inner space inadvertently opened.Moreover, the movement of connection plunger can open closed straight-through portion so that can close Straight-through portion closure member can by also be used for drive charging plunger and distribute plunger same linear actuating device open.

Preferably, hollow needle or pipe are arranged in connection plunger.In this context, the present invention can will preferably connect plunger It is arranged to be arranged in bracket from distribution plunger or barrel suitable distance in the case where storing the storing state with mixing apparatus, so that Hollow needle or pipe do not contact on the back side of barrel can closed access closure member.Therefore, hollow needle is not contacted preferably and can be sealed Close access penetrable septum or the pipe do not contact sealed lip or can closed access valve.However, if design is comprising close Lip is sealed, then manages and has preferably been guided through sealed lip.

Moreover, positive stops can be arranged on the front of bracket in the present invention, it limits connection plunger in the side of bracket Movement of the upward movement or connection plunger on the positive direction of bracket.

According to a preferred refinement scheme, the present invention can in the interconnecting piece of the liquid permeable of barrel, in bracket Front on be arranged permeable gas and liquid porous disc or sieve.

In this way, it can prevent the fragment of monomer fluid container or the component cut off from entering in bracket and in turn Into in bone cement.It can also enough preventing the fragment or component damage or blocking the permeable liquid between bracket and barrel The interconnecting piece of body.

The present invention can also set storage and mixing apparatus to bone cement applicator, and the bone cement applicator is for originating The storage and mixing of component and in spine regions apply bone cement dough, wherein the bone cement applicator is preferably Distribute opening including the extension that is arranged on the front of barrel, wherein extension distribution opening particularly preferably by distribution pipe, Hose and/or trochar are realized.

Storage and mixing apparatus can by being particularly suitable for be used as the bone cement applicator with cone vertebroplasty.Due to linear Two component types design and barrel are designed as to very narrow ability, the extrusion equipment of manual actuation may be used, although bone cement Dough is very viscous and distributes that opening is very long, and the latter may include which further adds flowings to hinder for trochar and hose- Power.This is because to drive storage and mixing apparatus and therefore the stroke distances of bone cement applicator are very long, and by In the inner space of barrel long and narrow design and thus relatively small internal diameter, long stroke squeezes out only expanded distribution opening on a small quantity Bone cement dough.

Preferably, extension distribution opening is realized by distribution pipe, for be attached hose or trochar adapter, especially It is that Luer system adapter is arranged in the distribution pipe.Preferably, hose has the internal diameter less than 4mm.Further preferably hose has 10 bars of minimum compression strength.

The storage and mixing apparatus for being intended as the bone cement applicator for spinal fusion can be suitably set It can be arranged in extension distribution opening or extend between distribution opening and barrel from the triple valve of peripheral operation at making, wherein Collection vessel for receiving bone cement dough is arranged in the triple valve, therefore extends to distribute to be open to converge to and be arranged in extension During the application away from the end of barrel on of distribution opening is open, wherein triple valve is appropriately designed so that, it is in the There is provided to apply when one position and fluidly connect and close the passing away towards collection vessel between opening and barrel, and in It is provided when the second position and applies fluidly connecting and closing the access towards barrel between opening and collection vessel.

This to act on extension distribution opening such as the pressure energy on the bone cement in hose when extrusion is interrupted It is eliminated by adjusting the triple valve being connect with collection vessel, hose and barrel, the bone cement cream without having any significant quantity Group continues to flow.Meanwhile this allows the pressure of bone cement dough and starting ingredient in barrel in triple valve surrounding and is especially It is maintained in mixer (if there is any pressure).As a result, triple valve is opened leaves it again with bone cement dough Between elapsed time it is very short.Therefore, the pressure of barrel is maintained between triple valve and distribution plunger when triple valve is closed, and The fast decompression of extension distribution opening is realized between triple valve and application opening, because bone cement dough is in closed position warp Triple valve flows away.Collection vessel has been configured to ensure that bone cement dough will not pollute ambient enviroment or user, and prevents bone water Mud dough is oozed through triple valve.Theoretically, bone cement dough is kept.Collection vessel can also be flexible and/or elastic And it can be expanded when it obtains the bone cement dough left from triple valve.

Therefore storage and mixing apparatus are the emergency pressure reducing valve (overflow valve) of triple valve comprising form, once bone cement dough Extrusion can be stopped by the emergency pressure reducing valve moment by beginning to flow into the unwanted areas of centrum.The emergency pressure reducing valve Serve as the decompressor for storing and the extension distribution of mixing apparatus is open, wherein the bone cement dough from upstream region Hangover pressure be blocked and at the same time positioned at emergency pressure reducing valve upstream bone cement dough by open lead to collection vessel Channel and depressurize, bone cement dough can exit into the collection vessel, until the pressure solution in hose and/or trochar It removes.

The storage and mixing apparatus are preferably able to be suitably arranged such that collection vessel can not permeate bone towards the outside Cement dough is preferably that collection vessel is liquid-tight or liquid-tight and airtight.Collection vessel can also be arranged by the present invention At including a volume, the volume be at least extend distribution opening, particularly hose and-be applicable in if-volume of trochar Half, preferably at least with extension distribution opening, particularly hose and-be applicable in if-volume of trochar as it is big.

The present invention can be between barrel and extension distribution opening or in extension distribution opening or between barrel and triple valve The mixer for mixing bone cement, especially static mixer are provided, wherein triple valve is preferably placed in mixer and extension Between distribution opening.In the later case, triple valve can be arranged to provide application opening in first position and mix by the present invention Fluidly connecting between the clutch and access of mixer is led in closing in the second position.

About including hose preferred storage according to the present invention and mixing apparatus, hose be at least in its multiple regions It is flexible.Extension distribution opening can also be arranged to terminate in the female connector of tool by the present invention, especially Rule In system adapter or in trochar.

The feature of preferred storage and mixing apparatus can also be that bracket includes attachment device, include especially at least one A hollow needle or at least one pipe are as attachment device, wherein the attachment device be arranged on the front of bracket and bracket with Conduct the mode of liquid through attachment device with or can be connect with the inner space of barrel, and wherein, bracket is in addition to attachment device Except close in fluid-tight manner.

As a result, especially can realize the connection between bracket and barrel by bracket.Moreover, attachment device is together with bracket It is removed together from barrel and therefore will not bring any interference when bone cement is extruded from barrel from now on.

Moreover, the present invention can be designed to, monomer fluid container can be by feeding plunger on the positive direction of bracket Movement and the inside of bracket open, it is can preferably breaking or peelable.

As a result, monomer fluid container can be opened by feeding the axial linear movement of plunger.Have therefore, it is possible to use The extrusion equipment of the axial linear driving device of only one so as to open monomer fluid container and will monomer fluid be pressed into barrel in And also bone cement dough is squeezed out from barrel.

According to a refinement scheme, storage according to the present invention can set monomer fluid container to mixing apparatus can In glass ampule, plastic ampoule, plastic film bag or the aluminium-plastic compound bag that the inside of bracket is opened.

The monomer fluid container is very suitable for the long term storage of monomer fluid and is also easy to break or tear in bracket It opens.

Preferably, the present invention can be designed to, the first fixing device and the second fixing device can be fixed on extrusion equipment, spy It is not on the single holder of barrel rifle.

As a result, it is possible to feed both plunger and distribution plunger using single extrusion equipment to drive.This simplifies storages With the operation of mixing apparatus.

Equally, the present invention is preferably able to set the inner space of barrel to cylindrical shape and can will distribute plunger Periphery is arranged to match with the inner space of barrel so that distribution plunger seals on the back side of barrel in barrel about outside Portion space.

As a result, storage and the design of mixing apparatus are simplified and manufacture at low cost.Moreover, including the geometry Distribution plunger cannot be so easily in place in the inner space of barrel so that storage and mixing apparatus are in this way Do not allow error-prone.

Barrel is preferably in a tubular form.

Moreover, the present invention can set the inner space of bracket to cylindrical shape and can set the periphery for feeding plunger It is set to and is matched with the inner space of bracket so that the inside that distribution plunger seals bracket about outside on the back side of bracket is empty Between.

As a result, storage and the design of mixing apparatus are simplified and manufacture at low cost.Moreover, including the geometry Charging plunger cannot be so easily in place in the inner space of bracket so that storage and mixing apparatus are in this way Do not allow error-prone.

Bracket is preferably in a tubular form.

Distribution opening can be also arranged in the present invention on the front of barrel, can be open and be discharged through the distribution by distribution plunger The content of barrel.

In this way, the opposite side in distribution plunger is arranged in distribution opening.As a result, the stream of viscous bone cement dough Dynamic resistance keeps low.

In order to drive storage and mixing apparatus, the present invention that can be designed to independently of any outside supplies, store Can be operated by manually operable extrusion equipment with mixing apparatus, distribution plunger can by manual force in barrel move with So that bone cement dough is extrudable, and feeds plunger and can be moved in bracket by hand-power so that monomer fluid container can be opened It opens and monomer fluid can be pressed into the inner space of barrel.

As a result, storage and mixing apparatus even also can reliably be made in the case of no motor and exterior source of energy With.

Moreover, the present invention can set the sectional area of the inner space of barrel to most 4cm², preferably up to 2.5cm², particularly preferably most 1.2cm²。

In this way, can ensure that will not be excessive for squeezing out the power of viscous bone cement dough inside barrel.As a result, Design can not only be simplified, and the extrusion equipment of manual actuation can be used.

Barrel can be arranged to close on front by barrel head by one preferred refinement scheme, wherein exit opening In barrel head and exit opening is closed by closure member, the finished ground cement in the impermeable barrel of the closure member and Permeable gas, especially millipore filter, wherein closure member are preferably by axial compressive force load or the work by hand-power For opening.

As a result, the inside of barrel and finished ground cement can be sterilized by the sterilizing gas of such as ethylene oxide.In addition, water Mud powder will not be escaped and be lost, otherwise this can distort the blending ratio of finished ground cement and monomer fluid and therefore distort bone water The composition of mud dough.

For the long term storage of finished ground cement, distribution plunger can be arranged to impermeable finished ground cement particle by the present invention And include the straight-through portion of permeable monomer fluid, wherein the straight-through portion be preferably arranged in distribution plunger towards the back side Side, and straight-through portion is closed.

The transmission of monomer fluid is moved forward and thus interfered along the direction of bracket this prevent finished ground cement.

The present invention bracket can also be arranged in fluid-tight manner by feed plunger or can close on the back side, preferably It is arranged to the closing of liquid-tight and air tight manner or can be closed with liquid-tight and air tight manner.

This prevent monomer fluids to leak backwards from bracket.This allows to ensure desired blending ratio.Moreover, can prevent Ambient enviroment is by monomer liquid body pollution.

According to a preferred embodiment, barrel can be arranged to fix dress in hollow circle tube and by second by the present invention It installs to be set to and be connect with extrusion equipment, wherein the front of barrel head containing vacuum cylindrical shape barrel, wherein on barrel head In be disposed with exit opening, and wherein, the exit opening is by the outside on barrel head in a manner of permeable gas and barrel The inside on head connects, wherein distribution pipe is connect with the exit opening on barrel head, wherein is provided with impermeable liquid The mode of body closes the penetrable septum at the back side of distribution plunger, and bracket is in hollow circle tube, wherein the company in bracket The porous disc for being provided with permeable gas and liquid in plunger is connect, and at least one sky is disposed on the front of connection plunger Heart needle, at least one hollow needle are connected in a manner of liquid permeable with the back side of porous disc by channel.

The design simplifies storage and mixing apparatus and keeps it especially cheap.

The present invention can set monomer fluid container to open by bearing pressure.In this way, monomer liquid Body container can for example be opened by the pressure-of extrusion equipment application by applying the power-of linear action.

The feature of preferred storage and mixing apparatus can be that the internal diameter of barrel is less than or equal to the internal diameter of bracket, excellent The internal diameter of selection of land barrel is less than the internal diameter of bracket.

In this way, squeezed out from barrel power needed for viscous bone cement dough by more long stroke come reduce without Unnecessarily big stroke is needed to open monomer fluid container and squeeze out monomer fluid from bracket.

According to a refinement scheme, the present invention can set and expect the volume of the monomer fluid in monomer fluid container to The volume of the air-filled clefts between finished ground cement particle in cylinder is equally big, is preferably set to the inner space with barrel The air-filled clefts between finished ground cement particle in the volume casing drum of fluid pipeline between the inner space of bracket Volume it is equally big.

In this way, it can be ensured that all finished ground cements can be soaked by monomer fluid and therefore generate homogeneous Bone cement dough.

In this context, the present invention is preferably able to the gap setting between the finished ground cement particle in barrel be to account for water Between the 22% of the volume of the bulk powder of mud powder and 40%.

In order to which hygienic requirements is more easily satisfied, the present invention may be designed to, and arrange that at least one ventilation is opened in the wall of bracket Mouthful, wherein the inner space of bracket of the vent openings by monomer fluid receptacle wherein is connect with ambient enviroment, In, at least one vent openings are preferably sufficiently closely arranged in the region of charging plunger so that in monomer fluid Container by feed plunger movement open before it by charging plunger sealed in the movement on the positive direction of bracket It closes.

As a result, sterilizing gas can be used to sterilize the inner space of bracket.Meanwhile when at least one vent openings are logical Cross the fortune fed when plunger is moved along the positive direction of bracket and is closed and in monomer fluid container by charging plunger It is dynamic and is opened-for example by the inner space of bracket the flattening of charging plunger, divide or tear-before, monomer fluid without Method is left from the inner space of bracket.

Preferably, the present invention barrel can also be arranged to have 10 Palestine and Israels on, in preferably 50 Palestine and Israels, particularly preferably 70 Compressive resistance (compression strength) in Palestine and Israel.

This makes the prodigious power occurred when squeezing out viscous bone cement dough from barrel that will not become to let out with barrel Leakage prevents the degree of the movement of distribution plunger that the wall of barrel is made to deform.

The purpose of the present invention is also by one kind for producing bone cement dough, particularly pasta polymethyl methacrylate The method of bone cement dough is realized, wherein bone cement dough is using storage and mixing apparatus by finished ground cement and monomer liquid system At, wherein storage and mixing apparatus include containing the bracket of the monomer fluid container with monomer fluid and containing water The barrel of mud powder, wherein the bracket is fixed on or can be fixed on the back side of barrel, and the method is characterized in that with following The step of order occurs and (carries out in succession)：

A) storage is inserted into mixing apparatus in extrusion equipment, wherein the extrusion equipment includes in axial direction promoting Push rod；

B) charging plunger is promoted towards the direction of the barrel by push rod, the charging plunger is in the bracket with movable side Formula is supported on the back side of the bracket, wherein the movement for feeding plunger opens monomer fluid container and by monomer fluid It is pressed into barrel from monomer fluid container, wherein the monomer fluid described in the inner space of barrel is mixed with the finished ground cement It closes；

C) bracket is detached with barrel, wherein barrel keeps in extrusion equipment or reinserts crowded after releasing Go out in equipment；

D) distribution plunger is promoted along the positive direction of barrel by push rod, the distribution plunger is in the barrel with movable Mode is supported on the back side of the barrel, wherein distributing the movement of plunger will be made of finished ground cement and monomer fluid Mixture is discharged in the form of bone cement dough from barrel.

In this context, the present invention is capable of providing the method implemented using storage according to the present invention and mixing apparatus.

Moreover, closed straight-through portion, monomer fluid warp in step b) can be arranged in the present invention on the back side of barrel The straight-through portion is pressed into the inside of barrel, wherein closed straight-through portion quilt when bracket is detached with barrel in step c) Closing or during the separation seal itself.

Straight-through portion is designed to that closed effect is, after monomer fluid is fed into barrel, monomer fluid It cannot be left through it on the back side of barrel after bracket is detached with barrel.In this way, it is therefore prevented that there is monomer liquid The pollution of the surgical field of body and/or stain.

Preferably, the first fixing device can be arranged on the back side of bracket and the is arranged on the back side of barrel by the present invention Two fixing devices, wherein during storing with insertion of the mixing apparatus in step a), storage and mixing apparatus are solid by first Determine device to be fixed on the holder of extrusion equipment, and barrel is fixed on extrusion equipment in step c) by the second fixing device Holder on.

In this way, both bracket and barrel can be fixed on the same holder such as barrel rifle of extrusion equipment, and Therefore bracket and barrel can be squeezed out using same extrusion equipment.Term " barrel rifle " should be understood as further including caulking gun.It is preferred that Use the extrusion equipment or barrel rifle of manual actuation.Therefore, the present invention can preferably provide be adapted and arranged to be fixed on it is crowded Go out the first fixing device and the second fixing device on the holder of equipment.

In order to simplify the implementation of this method, bracket can be arranged to be connected by screw by the present invention, plug connection, occlusion connect It connects or bolt (bayonet lock) is disengaged and is detached with barrel in step c).

In this way, bracket and being stably connected with for barrel are realized when the two is connected to each other and/or fixes.

Moreover, the present invention is capable of providing the connection plunger on the front for being arranged in bracket, wherein monomer fluid receptacle Between connection plunger and charging plunger, wherein connection plunger is while feeding plunger and being pushed into and in monomer fluid quilt Driven along the direction of barrel in step b) before in indentation barrel, wherein lead to access in barrel thus open so that Barrel inner space and bracket inner space also liquid permeable mode charging plunger and connection plunger between that This connection, wherein it is preferred that subsequently or simultaneously, which is opened by the movement for feeding plunger towards connection plunger, Plastics or glass ampule especially as monomer fluid container are crushed between charging plunger and connection plunger so that can be The monomer fluid being pressed into barrel is obtained in the inner space of bracket.

This so that fluidly connecting between the inner space of barrel and the inner space of bracket is only moved in connection plunger When just open.In this way, it can prevent the inner space of barrel from inadvertently being opened.Moreover, the movement of connection plunger Closed access can be opened so that the closure member of closed access can be by being also used for driving charging plunger and distributing plunger Same linear actuating device is opened.

Preferably, feed plunger and connect the barrel between plunger inner space and bracket inner space thus with can The mode of permeation liquid and the mode of impermeable finished ground cement are connected to each other.Further preferably monomer fluid container connection plunger with Small fragment is compressed or is crushed between charging plunger.

According to the method according to the invention refinement scheme, the present invention can provide expanded from barrel in step d) The mixture for distributing finished ground cement and monomer fluid that opening, distribution pipe, hose, trochar and/or static mixer extrude, because This generates bone cement in wherein or early in barrel.

This method can be particularly suitable for cone vertebroplasty.Due to linear two component types design and barrel can be designed as The manual actuation method using the extrusion equipment of manual actuation may be used in very narrow ability, although bone cement dough is very It is viscous and distribute that opening is very long, and distribution opening may include which in turns increases flow resistances for trochar and hose-. This is because to drive the stroke distances of storage and mixing apparatus very long, and since the long and narrow of the inner space of barrel is set Meter and thus relatively small internal diameter, long stroke is by the only a small amount of bone cement dough of expanded distribution opening extrusion.

Moreover, the present invention can provide be arranged in extension distribute be open in or barrel downstream can be from the threeway of peripheral operation Valve, wherein triple valve be placed in first position or be in first position, wherein triple valve provided when in first position from The inner space of barrel is expanded to distribute the continuously coupled of opening, and barrel is sent out by the extrusion of extrusion equipment in step d) It is raw, wherein the bone cement dough mixed by finished ground cement and monomer fluid is squeezed through triple valve and extension assigns Mouthful, and then generation step e), wherein triple valve is transformed into the second position, and wherein triple valve stops when in the second position Only triple valve is flowed through from barrel and extend the one of the bone cement dough under pressure in the triple valve downstream in distribution opening Part is pressed into through triple valve in collection vessel.

Moreover, triple valve can be arranged to be switched again to first position in the step f) after step e) by the present invention, And in this way, the expanded distribution opening of bone cement dough passes through triple valve by guiding again, wherein it is preferred that with given Order repeats step d), e) and f) one or many.

The present invention is based on following it has unexpectedly been discovered that：Storage and mixing apparatus are subdivided into two components and use is set Allow to use conventional extrusion equipment in two same or like fixing devices of connection extrusion equipment, wherein extrusion equipment First stroke first switches on monomer fluid container and by interconnecting piece of the monomer fluid through two components — that is, bracket and barrel- It is pressed into finished ground cement, and is detached with another component of storage and mixing apparatus with latter component — that is, bracket-, and Extrusion equipment is then act through the second stroke and squeezes out bone cement dough from barrel.As a result, the extremely thin barrel that internal diameter can be used small, So that very viscous bone cement dough remains to that the resistance of hose is overcome to be extruded and applies, without extrusion equipment to be designed as It is very long and narrow due to especially long push rod.As a result, the storage and mixing apparatus and method also can be used in vertebroplasty.

According to the method for the present invention and both storage according to the present invention and mixing apparatus are based on following common thought：Make Monomer fluid container is opened with the storage of two component types and mixing apparatus that initially connect and utilizes extrusion equipment by monomer liquid Body is transferred in extrusion equipment, then detaches barrel with remaining storage and mixing apparatus；Same extrusion equipment can be used from material Cylinder discharge bone cement.For this purpose, it is preferred that using identical fixing device on barrel and bracket, they are identical as on extrusion equipment Be relatively fixed device connection.Using the appropriately designed and/or appropriate method and step of storage and mixing apparatus, can use The extrusion equipment of manual actuation.Moreover, adequate measure according to the present invention is the storage in bone cement dough and mixing periods, There is no monomer fluid and bone cement dough to be left from storage and mixing apparatus and pollutes environment.Finally, measure according to the present invention Storage and mixing apparatus is allowed to designed to be used the disposable products of disposable health.

The particular advantage of storage according to the present invention and mixing apparatus is, can use for common PMMA cement For common conventional manual driving extrusion equipment come through thin hose by for the bi-component vertebra cement of vertebroplasty and/ Or bone cement dough is expressed into trochar.The enhancing of centrum occurs under lasting x-ray control.In trochar and applicator Between setting hose allow doctor that need not make using his manual in the range of x-ray.In this context, do not need it is complicated, Expensive hydraulic pressure bringing device.

Moreover, it was unexpectedly found that, connection that can be on the back side of barrel between closed two components allows barrel It is separated with remaining storage and mixing apparatus after monomer fluid is supplied in finished ground cement, remaining monomer fluid will not It is left on the back side of barrel.Meanwhile the system is carried out rapidly using preparation, and can be operated like a dream.It should Storage and mixing apparatus can be used as the disposable products of health, because it can mainly be made of plastics, and can use Ethylene oxide by including inner space all components and finished ground cement sterilize.

Description of the drawings

More exemplary embodiments of the present invention will hereinafter be shown based on 14 not limit the scope of the invention Intention illustrates.In the accompanying drawings：

Fig. 1：The schematic sectional view of storage and mixing apparatus according to the present invention is shown；

Fig. 2：Storage according to Fig. 1 and the schematic side elevation of mixing apparatus are shown.

Fig. 3：Show self overlapping according to four schematic sectional views of the storage of Fig. 1 and 2 and mixing apparatus with Illustrate workflow according to the method for the present invention；

Fig. 4：It shows through the storage and mixing apparatus for distributing the present invention according to Fig. 1 to 3 that opening connects with extension The schematic sectional view of front；

Fig. 5：Three schematic perspective views of the component of the storage and mixing apparatus according to the present invention of Fig. 1 to 4 are shown；

Fig. 6：It is shown as the schematic sectional view of the detail drawing of the triple valve for being open according to the extension distribution of Fig. 4；

Fig. 7：It is shown as the schematic sectional view of the detail drawing of the triple valve according to Fig. 6, midship section is perpendicular to bone cement The flow direction of dough；

Fig. 8：Made at it as two components of storage and mixing apparatus according to the second width figure from the top in Fig. 3 With the schematic sectional view of the detail drawing of the connection of period；

Fig. 9：It is distributed according to two components as storage and mixing apparatus of the 4th width figure from the top in Fig. 3 The schematic sectional view of the detail drawing of preceding connection；

Figure 10：It is shown as the schematic of detail drawing of the back side of the rear component of storage and mixing apparatus under initial state Local perspective view (top) and schematic partial cross-sectional view (bottom)；

Figure 11：It shows through replaceability according to the present invention storage and the valve system of mixing apparatus — that is, in the closed position Two schematic perspective sectional views of triple valve-of (at the top of Figure 11) and open position (bottoms Figure 11)；

Figure 12：It shows through according to the valve system of Figure 11 — that is, (bottoms Figure 12) in an open position and closed position (figure 12 top) triple valve-two schematic, sectional top views；

Figure 13：The schematic sectional view of the third exemplary embodiment of the present invention through storage and mixing apparatus is shown； And

Figure 14：Amplification of two components according to the third exemplary embodiment of Figure 13 before extrusion starts is shown Detail drawing.

For purposes of clarity, identical reference numeral is used to some identical components in figure, even if embodiment is different.

Specific implementation mode

Fig. 1 to 5 shows the various schematic diagrames of the first example memory and mixing apparatus according to the present invention.Fig. 6 and 7 is shown Detail view as the valve system through the part that can be used as the storage and mixing apparatus according to the present invention of Fig. 1 to 5 Schematic sectional view.Fig. 8 to 10 shows the other detail view of the storage and mixing apparatus of the present invention according to Fig. 1 to 5.

Storage and mixing apparatus, which have, is used as front component (in left side in top, Fig. 3,5,6,8 and 9 in Fig. 1,2 and 4) The barrel 1 being made of plastics, the barrel have columnar inner space.Barrel 1 with for glass ampule 3 (or plastics pacify Small jar 3) the bracket 2 being made of plastics it is separably attached.Bracket 2 also include be inserted for glass ampule 3 it is columnar Inner space.Monomer fluid 4 is located in glass ampule 3.Finished ground cement 5 is filled or is preferably pressed into the inner space of barrel 1 In.Monomer fluid 4 and finished ground cement 5 are the starting ingredients 4,5 for the PMMA bone cements that can use storage and mixing apparatus production.By In glass ampule 3, monomer fluid 4 can be stored in bracket 2 and be stored in turn in storage and mixing apparatus for a long time.

The charging plunger 6 being made of plastics is disposed in bracket 2, which can be in the columnar inside of bracket 2 It moves longitudinally in space.Charging plunger 6 is arranged in the rear surface regions of bracket 2.Glass ampule 3 can be by along positive side To, i.e. along the direction of barrel 1 push charging plunger 6 and in bracket 2 by charging plunger 6 compress and thus split.Feed plunger 6 Include on the front face scraping blade (wiper), the fragment of glass ampule 3 can be scraped off from the inner wall of bracket 2 by the scraping blade.

The arrangement in the back side (towards bottom in Fig. 1,2 and 4, towards right side in Fig. 3,5,6,8 and 9) of the inner space of barrel 1 There is the distribution plunger 7 being made of plastics.Fixing device 8 is arranged on the back side of bracket 2 and can be used for bracket 2 and extrusion Equipment 43 (be not shown in Fig. 1, but be shown in figure 3) connects.The fixed dress of same design is provided on the back side of barrel 1 Set 9.Therefore both bracket 2 and barrel 1 can be fixed on same extrusion equipment 43.Fixing device 8,9 is preferably suitable for and sets It sets and is used to form bolt (bayonet lock) 8,9.In this way, the charging plunger 6 that can be freely reached from the back side of bracket 2 can make Be driven forwards along positive direction with the identical extrusion equipment of distribution plunger 7 43, when barrel 1 do not connect with bracket 2 (referring to Such as Fig. 4) when, distribution plunger 7 can be freely reached from the back side of barrel 1.

Barrel 1 and bracket 2 via the internal thread 11 on the back side of external screw thread 10 and barrel 1 on the front of bracket 2 each other Separably attached or energy is separably attached.Bracket 2 and barrel 1 are by means of the pipe 12 made of metal or plastics or distribution column Straight-through portion 14 in plug 7 is connected to each other about monomer fluid 4 in a manner of liquid permeable.Through the straight-through portion of distribution plunger 7 14 millipore filters 16 through impermeable finished ground cement 5 but permeable monomer fluid 4 converge in the inner space of barrel 1. Before the inner space into feeding cylinder 1, straight-through portion 14 is branched off into multiple arms, wherein each arm according to the sectional view of Fig. 1 not by It shows, is shown and in the central plane of storage and mixing apparatus shown in section because they are not located at.

Be disposed in the interconnecting piece of the pipe 12 in bracket 2 can be to the filter for the fragment for keeping glass ampule 3 18.Alternative solution as filter 18 or the additional aspects as filter 18 can also only be arranged or also set up sieve.Filtering Device 18 is arranged in connection plunger 20, and pipe 12 is also secured on the connection plunger 20.In the present embodiment, including connection plunger 20 Side contacts against on the front of bracket 2 and is only used for promoting storage and the assembling of mixing apparatus.Theoretically, pipe 12 and filter 18 Also it can only be affixed on bracket 2 and connection plunger 20 can be omitted.

Pipe 12 is directed by the allocated plunger of valve 7 for having there are three sealed lip 22 in straight-through portion 14.These three are close It seals lip 22 by the Y shape notch in an elastoplastic plug to implement, wherein plastics stop part forms the back part of distribution plunger 7 Point.Under initial state, pipe 12 is guided through the sealed lip 22, and access 14 is by contacting against the sealing on pipe 12 Lip 22 is sealed on direction in fluid-tight manner overleaf.When pipe 12 is drawn out from plug and/or sealed lip 22, sealing Overleaf side seals distribution plunger 7 and and then sealing material cylinder 1 to lip 22 in fluid-tight manner.

Columnar connection plunger 20 has the periphery with the cylindrical shape geometric match of the inner space of bracket 2, and And the inner wall about bracket 2 is sealed by two circumferential seals 24 in fluid-tight manner.Equally, charging plunger 6 passes through two circumferential directions Sealing element 26 seals in fluid-tight manner about the inner wall of bracket 2, and distributes plunger 7 by two circumferential seals 28 about barrel 1 inner wall seals in fluid-tight manner.Moreover, when barrel 1 and bracket 2 are fixed to each other, barrel 1 and bracket 2 are by being fixed on support Sealing element 30 in the front surface of seat 2 is about sealed against one another.The purpose of all sealing elements 24,26,28,30 is all to prevent Monomer fluid 4 or bone cement leave, to prevent the pollution of ambient enviroment (operating room and user).For this purpose, sealing element 24, 26, it 28,30 can be made of rubber.

In addition, the shell 32 that is made of plastics of bracket 2 surrounds, wherein when barrel 1 is connect with bracket 2, shell 32 and Bracket 2 connects and covers the fixing device 9 of barrel 1 on front.Barrel 1, bracket 2 and shell 32 can be by injection-molded It is made.

The front of barrel 1 is convergeed to including in externally threaded distribution pipe 34.Being disposed in the inside of distribution pipe 34 can not ooze The millipore filter 36 of saturating finished ground cement 5 but permeable gas.Cap 38 is fixed on the external screw thread of distribution pipe 34, wherein cap 38 front part is filled with foamed polystyrene or foam 40.There are two wing plates 42 for setting in cap 38 so that cap 38 It can easily be screwed off from distribution pipe 34 in a manner of thumb screw.Cap 38 includes lateral openings.It, can due to this design The inside of barrel 1 and finished ground cement 5 are sterilized by means of oxireme, this is because opening, foam polyphenyl second in cap 38 The gap air permeable of alkene or foam 40, millipore filter 36 and finished ground cement 5 detached between particle.Meanwhile when into When stock column plug 6 is extruded along the direction of bracket 2, air can through finished ground cement 5, millipore filter 36, foamed polystyrene or Opening in foam 40 and cap 38 is forced out from bracket.

Finished ground cement 5 is encapsulated in barrel 1, because all openings are all closed by millipore filter 16,36 and make water Mud powder 5 is impermeable.In this context, the content of barrel 1 can be disappeared by evacuating and being rinsed using ethylene oxide Poison.In this way, storage and mixing apparatus are also admirably suitable for the long term storage of finished ground cement 5.

Fig. 3 show self overlapping according to the storage of Fig. 1 and 2 and four schematic sectional views of mixing apparatus to say Bright workflow according to the method for the present invention.When this method starts, storage and mixing apparatus are in and are also shown in Fig. 1 Initial state.Correspondingly, the barrel 1 and bracket 2 of storage and mixing apparatus are initially connected to each other by screw thread 10,11.Locating When this state, storage and mixing apparatus are inserted into the extrusion equipment 43 that form is conventional barrel rifle and utilize fixing device 8 are fixed on the extrusion equipment 43 (referring to the description of topmost in Fig. 3).The front part of only extrusion equipment 43 is shown. Extrusion equipment 43 includes the push rod 44 that can be linearly promoted.Preferably, push rod 44 is by manual actuation.Push rod 44 is on the front face It terminates in the cup 46 that can be used to be pushed on charging plunger 6.For this purpose, extrusion equipment 43 passes through the device that is relatively fixed 48 connect with the back side of bracket 2 so that when push rod 44 is advanced to, cup 46 is pushed on charging plunger 6 and along barrel 1 Direction promote it.For this purpose, be supported to can be about bearing 50 and by it about the device that is relatively fixed for push rod 44 48 and therefore about 2 linear movement of bracket.

It operates extrusion equipment 43 and promotes push rod 44, and charging plunger 6 is promoted along the direction of barrel 1 by push rod 44. Since plastics or glass ampule 3 contact against connection plunger 20 on the front of connection plunger 20, so the ruler of the inner space of bracket 2 Very little reduction, glass ampule 3 is broken and monomer fluid 4 is from the inner space that glass ampule 3 exits into bracket 2.The situation It is shown in the enlarged detail in the second width figure and Fig. 8 from top in figure 3.Upper layer air from bracket 2 is pushed Micro porous filtration is passed through by the gap between the particle of finished ground cement 5 by filter 18, straight-through portion 14, millipore filter 16 Device 36 is forced out by foam 40, and via the opening in cap 38 from storage and mixing apparatus.

Finally, the fractionlet 52 of only glass ampule 3 remains and is kept and remained in bracket 2 by filter 18.It is single Body fluid body 4 is pressed into finished ground cement 5 through filter 18, straight-through portion 14 and millipore filter 16 and starts wherein and cement Powder 5 reacts so that generates bone cement dough 54 from mixture 54.The situation quilt from the third width figure top in figure 3 It shows.In addition, the barrel 1 with extension distribution opening is also shown in figures 4 and 5.In this stage, storage and mixing apparatus It is taken out from extrusion equipment 43.Bracket 2 and shell 32 are screwed off from barrel 1.In addition, with millipore filter 36 and foam 40 Cap 38 is screwed off and extends distribution opening and is swirled in distribution pipe 34.Then, 1 quilt of barrel of extension distribution opening is carried It is once again secured on extrusion equipment 43.Before this, extrusion equipment 43 is reset, i.e., push rod 44 is pushed back and is transitioned into start bit again It sets.After pipe 12 is drawn out, sealed lip 22 is closed by the effect of their own so that when barrel 1 and bracket 2 separate When (referring further to the specific enlarged detail according to Fig. 9), in straight-through portion 14 there are still monomer fluid 4 can not be in the back of the body of barrel 1 It is left on face.

The device 48 that is relatively fixed of extrusion equipment 43 is engaged with the fixing device 9 on the back side of barrel 1, to squeeze out Equipment 43 is fixed on barrel 1.Since the fixing device 8 in the fixing device 9 and bracket 2 on barrel 1 is identical, so both The same of same extrusion equipment 43 can be fixed on to be relatively fixed on device 48.This simplifies design and make it possible to With conventional extrusion equipment 43.In this context, fixing device 8,9 and the device 48 that is relatively fixed form bolt.

Extension distribution opening includes can be through T-handle 58 from the triple valve 56 of external manual manipulation.Triple valve 56 is with tight Matching seat is placed in the pipe 59 to form valve seat 59.Fig. 6 and 7 be shown as through can be used as according to Fig. 1 to 5 the present invention The schematic sectional view of the detail drawing of the valve system of a part for storage and mixing apparatus.Receipts are disposed in the region of triple valve 56 Collect container 60, which is closed relative to outside and for receiving bone cement dough 54.It is arranged in pipe 59 tangible At the access 61 of the inside of pipe 59.Access 61 on the front of pipe 59 can be connect via triple valve 56 with container 60 so that be added The bone cement dough 54 of pressure can be escaped from the front of extension distribution opening to the position so that when triple valve 56 is in the pass When closed position, at most only a small amount of bone cement dough 54 continues to distribute open flow from extension.As a result, continuing the bone cement of flowing The amount of dough 54 is reduced by the use of triple valve 56.Triple valve 56 is swirled to by means of wing plate 62 in distribution pipe 34. The front part of pipe 59 is connect with the hose 64 convergeed in trochar 66.

The back portion that do not screw on — that is, the bracket 2 for wherein carrying fragment 52 of storage and mixing apparatus and shell 32-guarantor It holds at rear and can be dropped.There is the protection pipe 68 being disposed thereon, pipe 12 to be disposed in the protection in the front of bracket 2 So that user is not easy the injury on pipe 12 in pipe.

Bone cement dough 54 can be distributed through hose 64 and trochar 66.For this purpose, distribution plunger 7 is by 44 He of push rod Cup 46 is pushed into along the direction of distribution pipe 34.When triple valve 56 is opened, in Fig. 3 (bottom diagram) and as shown in Fig. 6 and 7, 54 the allocated pipe 34 of bone cement dough is discharged through triple valve 56 and access 61, through hose 64 and trochar 66, and can be It is wherein applied to the vertebra of patient or is theoretically used to further handle.Triple valve 56 can be operable to middle knochenbruch water The flowing of mud dough 54.Pressurization bone cement dough 54 from hose 64 and trochar 66, which can flow into collect through triple valve 56, to be held Without polluting ambient enviroment in device 60.In this way, the flowing of bone cement dough 54 is interrupted rapidly.

Trochar 66 connect with hose 64 through Luer system adapter 70 (referring in Fig. 4 or Fig. 5 from upper left quarter second Embodiment).The trochar 66 can be equally directly connected to hose 64.The first embodiment of the upper left quarter of Fig. 5 shows a change Luer system adapter 74 is connect via short hose 76 with barrel 1 by type, wherein connector 72.Connector 72 can be with wing The mode of screw is screwed around by means of wing plate 78 in the distribution pipe 34 of barrel 1.For this purpose, connector 72 includes matched Internal thread.

The specific amplification detail view according to Fig. 6 of valve system also shows pipe 59 and is connect with hose 64 by insertion piece 80, The insertion piece 80 includes the channel being aligned with access 61.For this purpose, insertion piece 80 is swirled in pipe 59.In order to ensure closed Connection, hose 64 is clamped to by metal sleeve 82 on insertion piece 80, and pipe 59 by two circumferential seals 84 about point The inner wall sealing of piping 34.The downside of triple valve 56 is fixed using stop part 86 so that triple valve 56 cannot be from valve seat 59 or pipe 59 are easily pulled.The visible passing away 88 in valve seat 59 in the section according to Fig. 7, the passing away are vertical It positions in the section according to Fig. 6 and perpendicular to access 61, wherein in the case where triple valve 56 is in the closed position, bone water Mud dough 54 can be flowed into through the passing away in collection vessel 60 from the front of extension distribution opening.

Figure 10 is shown as the schematic of the detail drawing of the back side of the rear portion of storage and mixing apparatus in a start up state Local perspective view (top) and schematic partial cross-sectional view (bottom).It can be seen that the wall of bracket 2 is provided with multiple vent openings 90, energy Enough sterilizing gas by means of such as ethylene oxide sterilize the inner space of bracket 2 through the vent openings 90.Vent openings 90 arrange close to charging plunger 6 so that when charging plunger 6 is pushed into along the direction of barrel 1, charging plunger 6 is closed logical immediately Gas opening 90.It is left through vent openings 90 when the glass ampule 3 that this prevent monomer fluids 4 in bracket 2 is opened.

Figure 11 and 12 is shown through exemplary three for the second replaceability according to the present invention storage and mixing apparatus Two perspective schematic views of port valve 102, that is, (at the top of Figure 11 and at the top of Figure 12) in the closed position and in an open position The triple valve 102 at (bottoms Figure 11 and the tops Figure 12), to illustrate the functional mode of the triple valve 102 by interior design.

The storage of replaceability second and the design of mixing apparatus according to the present invention and the foregoing First example according to Fig. 1 to 10 Property embodiment it is identical, unless otherwise description or it is visible in figs. 11 and 12.

Pipe 103 be arranged on the front of barrel as extension distribution opening (be not shown barrel in figs. 11 and 12, but it with Equally it is arranged in the exemplary embodiment of front).The hose 104 of bone cement dough can be distributed through it (in figs. 11 and 12 not show Go out) it is fixed on valve system in the downstream of valve system.In order to ensure bone cement dough cannot be left in a manner of uncontrolled, collect Container 109 is similar to according to Fig. 6's and 7 and embodiment is arranged and for receiving the bone cement left from triple valve 102.Pass through This mode, it is therefore prevented that ambient enviroment — that is, especially operative region-is polluted by bone cement.Hose 104 is via clamping connector It is connect with valve system with air-tight manner by sleeve 112 made of metal.

The static mixer 114 for extending to triple valve 102 is located at the inside of pipe 103.Static mixer 114 is used for Bone cement and/or the starting ingredient of the bone cement dough of premixing play these when being pressed into pipe 103 through static mixer 114 Beginning component mixes.

In the sectional view according to Figure 11 and 12, the symmetrical plane in the visible channel wherein of rotatable triple valve 102 In be cut.Therefore, channel is cylindrical and is continued in being cut open in part for triple valve 102 with mirror image.These Channel forms the T shape components in triple valve 102.Triple valve 102 is located in the valve seat 116 of cooperation, which exists in each channel It closely contacts against on triple valve 102 when being rotated in valve seat 116 and therefore seals each channel.Valve seat 116, which has, to be located therein Two paths 119, larger through channel in triple valve 102 can by described two accesses in side in a manner of fluid-tight And pipe 103 connects and in the other side and the connection of insertion piece made of metal 118 to be attached hose 104.

The passing away 120 that valve seat 116 is connect with the inside of closed collection vessel 109 towards the outside is logical perpendicular to two The axis location on road 119.Valve seat 116 and pipe 103 are arranged to the single component made of plastic material.In triple valve 102 Open position (bottoms Figure 11, Figure 12 at the top of), big pass through openings are connect and small in triple valve 102 with two paths 119 Vertical channel closed by valve seat 116.Therefore, the bone cement dough from barrel through triple valve 102 and can be inserted from pipe 103 Enter part 118 to flow into hose 104.In the closed position (Figure 11 at the top of and the bottoms Figure 12) of triple valve 102, big through channel Side is connect with the passing away 120 for the inner space for leading to collection vessel 109, and smaller vertical channel and leads to hose 104 access 119 connects, and another access 119 for leading to pipe 103 is closed by triple valve 102.Therefore, bone cement dough energy It is enough to be flowed out from hose 104, also, under applicable circumstances, from the Luer system adapter (not shown) being connect with hose 104 And/or connected trochar (not shown) flows out in collection vessel 109.Pressure for this purpose is by hose 104 and suitable The flexible deformation for the trochar established during extrusion and/or while bone cement dough is squeezed through in the case of Cause.

Triple valve 102 can exist by control unit (not shown) such as T-handle (referring to the exemplary embodiment of front) It is manually turned in valve seat 116.By cylindrical on the outside, triple valve 102 is conducted through the cylinder-shaped hole in valve seat 116 Chamber simultaneously (is not shown, but similar to the exemplary of front in the opposite side of control element (not shown) and stop part in Figure 11 and 12 Embodiment is arranged) it connects and is therefore pulled out to prevent dropping out or being inadvertently valve seat 116.

Due to design according to the present invention, triple valve 102 can be closed by rotation and therefore to interrupt bone cement rapidly The flowing of dough, without having, a large amount of bone cement doughs continue to flow through hose 104 or trochar converges to application opening therein (not shown).Meanwhile by the collection vessel 109 for picking up any excessive bone cement dough prevent bone cement dough leakage and Therefore the pollution of ambient enviroment or user.Moreover, in the back side of bone cement applicator — that is, the distribution column of triple valve 102 and barrel Between plug-pressure be maintained so that bone cement dough can be provided rapidly again after triple valve 102 is again turned on It flows without establishing pressure again on the back side of storage and mixing apparatus.

Figure 13 and 14 shows two schematic sectional views of third replaceability storage and mixing apparatus according to the present invention. This, Figure 13 shows the schematic sectional view through third exemplary embodiment according to the present invention, and Figure 14 is shown according to figure The specific enlarged detail of connection of two components of 13 third exemplary embodiment before extrusion starts.

The storage of third replaceability and the design of mixing apparatus according to the present invention and the first exemplary reality according to Fig. 1 to 10 It is identical to apply example, unless otherwise description or in Figure 13 and 14 it is visible.

Storage and mixing apparatus have as elevational element (in left side in top and Figure 14 in Figure 13) by plastics Manufactured barrel 201, the barrel have columnar inner space.Barrel 201 with for (or the plastic ampoule of glass ampule 203 203) the bracket 202 being made of plastics is separably attached.Bracket 202 also includes the circle being inserted for glass ampule 203 The inner space of tubular.Monomer fluid 204 is located in glass ampule 203.Finished ground cement 205 is filled or is preferably pressed into barrel In 201 inner space.Monomer fluid 204 and finished ground cement 205 are the PMMA bone water that can use storage and mixing apparatus production The starting ingredient 204,205 of mud.Due to glass ampule 203, monomer fluid 204 can be stored in bracket 202 and and then store It is storing and some time in mixing apparatus.

Be disposed in bracket 202 can move longitudinally in the columnar inner space of bracket 202 by plastics system At charging plunger 206.Charging plunger 206 is arranged in the rear surface regions of bracket 202.Glass ampule 203 can be by along just The direction in face, i.e. along the direction of barrel 201 push charging plunger 206 and in bracket 202 by charging plunger 206 compress and thus It splits.It includes scraping blade to feed plunger 206 on the front face, can scrape off glass peace from the inner wall of bracket 202 by the scraping blade The fragment of small jar 203.

It is disposed with by plastics in the back side (in Figure 13 towards in bottom and Figure 14 towards right side) of the inner space of barrel 201 Manufactured distribution plunger 207.Fixing device 208 is arranged on the back side of bracket 202 and can be used for setting bracket 202 with extrusion Standby (being not shown in Figure 13 and 14) connects.The fixing device 209 of same design is provided on the back side of barrel 201.Bracket 202 It therefore can be fixed on same extrusion equipment with 201 the two of barrel.Fixing device 208,209 is preferably suitable for and is arranged to be used for Form bolt.In this way, it can be used by the charging plunger 206 freely reached from the back side of bracket 202 and distribute column 207 identical extrusion equipments are filled in be driven forwards along positive direction, it, can be from barrel when barrel 201 is not connect with bracket 202 201 back side freely reaches the distribution plunger 207.

Barrel 201 and bracket 202 are via the interior spiral shell on the back side of external screw thread 210 and barrel 201 on the front of bracket 202 Line 211 is separably attached each other or can be separably attached.Bracket 202 and barrel 201 can be by means of being made of metal Hollow needle 212 or distribution plunger 207 in straight-through portion 214 connected each other in a manner of liquid permeable about monomer fluid 204 It connects.Through micropore mistake of the straight-through portion 214 through impermeable finished ground cement 205 but permeable monomer fluid 204 of distribution plunger 207 Filter 216 converges in the inner space of barrel 201.Straight-through portion 214 is at it into being branched off into before the inner space of feeding cylinder 201 Multiple arms.

Be disposed in the interconnecting piece of the hollow needle 212 in bracket 202 can be keeping the fragment of glass ampule 203 Filter 218.Alternative solution as filter 218 or the additional aspects as filter 218 can also only be arranged or go back Sieve 218 is set.Filter 218 is arranged in connection plunger 220, which is arranged to also in the inside of bracket 202 It is moved in space and with the hollow needle 212 being fixed thereon.In this context, hollow needle 212 is formed through connection plunger 220 Access.In the present embodiment, connection plunger 220 is located at a certain distance from the front from bracket 202.In the present embodiment, it holds in the palm Connection between the inner space and the inner space of barrel 201 of seat 202 is only generated when connecting plunger 220 and moving.

During the movement of connection plunger 220, hollow needle 212 pierces through elastic diaphragm 242 (referring to Figure 14).Work as hollow needle 212 from diaphragm 242 when being drawn out, diaphragm 242 overleaf sealing distribution plunger 207 and and then sealing material cylinder 201 in fluid-tight manner. From field of medicaments such diaphragm 242 is learnt for extracting the container of syringe.

Columnar connection plunger 220 has the periphery with the cylindrical shape geometric match of the inner space of bracket 202, And the inner wall about bracket 202 is sealed by two circumferential seals 224 in fluid-tight manner.Equally, charging plunger 206 passes through two A circumferential seal 226 seals in fluid-tight manner about the inner wall of bracket 202, and distributes plunger 207 by two circumferential seals Part 228 seals in fluid-tight manner about the inner wall of barrel 201.Moreover, when barrel 201 and bracket 202 are fixed to each other, barrel 201 and bracket 202 by the sealing element 230 that is fixed in the front surface of bracket 202 about sealed against one another.All sealing elements 224,226,228,230 purpose be to prevent monomer fluid 204 or bone cement from leaving so as to prevent ambient enviroment (operating room and User) pollution.For this purpose, sealing element 224,226,228,230 can be made of rubber.

In addition, the shell 232 that bracket 202 is made of plastics surrounds, wherein when barrel 201 is connect with bracket 202, shell Body 232 connect with bracket 202 and covers the fixing device 209 of barrel 201 on front.Barrel 201, bracket 202 and shell 232 can be made up of injection-molded.

The front of barrel 201 is convergeed to including in externally threaded distribution pipe 234.It is disposed with not in the inside of distribution pipe 234 The millipore filter 236 of permeable cement powder 205 but permeable gas.Cap 238 is fixed on the external screw thread of distribution pipe 234 On, wherein the front part of cap 238 is filled with foamed polystyrene or foam 240.Cap 238 can be from 234 quilt of distribution pipe It screws off.Cap 238 includes lateral openings.It, can be by means of oxireme by the inside of barrel 201 and cement due to this design Powder 205 sterilizes, this is because the opening, foamed polystyrene or foam 240, millipore filter 236 in cap 238 and water Gap air permeable between the separation particle of mud powder 205.Meanwhile when charging plunger 206 is squeezed along the direction of bracket 201 When pressure, air can be through in finished ground cement 205, millipore filter 236, foamed polystyrene or foam 240 and cap 238 Opening is forced out from bracket.

Finished ground cement 205 is encapsulated in barrel 201, because all openings are closed by millipore filter 216,236, so that Finished ground cement 205 cannot penetrate.In this context, the content of barrel 201 can be rinsed by evacuating and using ethylene oxide And it is sterilized.In this way, storage and mixing apparatus are also admirably suitable for the long term storage of finished ground cement 205.

Workflow according to the method for the present invention is discussed below based on third exemplary embodiment.Start in this method When, storage and mixing apparatus are in the also initial state shown in Figure 13 and 14.Therefore, the barrel of storage and mixing apparatus 201 and bracket 202 be initially connected to each other by screw thread 210,211.In a state in which when, storage and mixing apparatus be inserted into shape In extrusion equipment of the formula for conventional barrel rifle, and it is fixed on extrusion equipment using fixing device 208.

Extrusion equipment includes push rod, which can be by linear advancement and similar to the extrusion equipment according to Fig. 1 to 10 43 designs.Extrusion equipment 43 is connect through the device that is relatively fixed with the back side of bracket 202 so that when push rod is advanced to, Push rod is pushed on charging plunger 206 and promotes it along the direction of barrel 201.For this purpose, be supported to can be about for push rod The device that is relatively fixed is simultaneously therefore about 202 linear movement of bracket.

It operates extrusion equipment and promotes push rod, and to promote along the direction of barrel 201 by push rod and feed plunger 206.By It is contacted against on the front of connection plunger 220 in glass ampule 203 or plastic ampoule 203, so connection plunger 220 is along barrel 201 Direction pushed.Hollow needle 212 pierces through diaphragm 242 and plug 222.The purpose of plug 222 is to sterilize hollow needle 212. Which establishes the liquid conductive connections between the inner space of barrel 201 and the inner space of bracket 202.Due to feeding plunger 206 movement, charging plunger 206, which is enclosed in, to be arranged in the wall of bracket 202 in the region of charging plunger 206 and allows bracket 202 inner space is drained and uses the vent openings (not shown) of oxirane disinfection under initial state.Connect plunger 220 are pushed against on the front of the inner space of bracket 202 and can not further move.As a result, the inside of bracket 202 is empty Between size reduce when feeding plunger 206 and being further promoted, glass ampule 203 is broken, and monomer fluid 203 is from glass Ampoule 203 exits into the inner space of bracket 202.Upper layer air from bracket 202 be pushed through filter 218, Straight-through portion 214, millipore filter 216, by the gap of finished ground cement 205, by millipore filter 236, by foam 240, And it is forced out from storage and mixing apparatus via the opening in cap 238.

Finally, the fractionlet of only glass ampule 203 remains and is kept and remained in bracket 202 by filter 218. Monomer fluid 204 is pressed into through filter 218, straight-through portion 214 and millipore filter 216 in finished ground cement 205 and wherein Start to react with finished ground cement 205 so that generate bone cement dough from mixture.In this stage, storage and mixing apparatus are from squeezing Go out equipment to be removed.Bracket 202 and shell 232 are screwed off from barrel 201.In addition, carrying millipore filter 236 and foam 240 Cap 238 screwed off and extend distribution opening be swirled in distribution pipe 234.Then, the material of extension distribution opening is carried Cylinder 201 is once again secured on extrusion equipment.Before this, extrusion equipment is reset, i.e., push rod is pushed back and is transitioned into starting again Position.After hollow needle 212 is drawn out, diaphragm 242 is closed by its own effect so that when barrel 201 and bracket 202 divide From when, in straight-through portion 214 there are still monomer fluid 204 cannot be left on the back side of barrel 201.

In order to which extrusion equipment to be fixed on barrel 201, the device that is relatively fixed of extrusion equipment is at the back side of barrel 201 Upper to be engaged with fixing device 209, fixing device 209 is also used for being fixed in the fixing device 208 of bracket 202.Due to barrel 201 On fixing device 209 and bracket 202 on fixing device 208 it is identical, so both can be fixed on it is same extrusion set It is standby same to be relatively fixed on device.This simplifies design and make it possible to use conventional extrusion equipment.In this context, fixed Device 208,209 and the device that is relatively fixed preferably form bolt.

Extension distribution opening can preferably include the triple valve similar to first or second embodiments.Equally, hose and/ Or trochar can be connect with distribution pipe 234.

The support of the back portion screwed off — that is, the part 203 for wherein carrying glass ampule 203 of storage and mixing apparatus Once seat 202 and shell 232-they screwed off and just can be dropped.The front of bracket has the protection pipe being disposed thereon 268, hollow needle 212 is arranged such that user will not be easily injured on hollow needle 212 in the protection pipe.

Bone cement dough can be distributed through hose and trochar or the allocated pipe 234.For this purpose, plunger 207 is distributed It is pushed into along the direction of distribution pipe 234 by push rod.Or the allocated pipe 234 of bone cement dough from the inside of barrel 201 is straight Run in or the allocated pipe 234, triple valve, hose and trochar are discharged in the case where triple valve is opened, and can be herein It is applied to the vertebra of patient or is theoretically used to further handle.Triple valve can be operable under applicable circumstances Interrupt the flowing of bone cement dough.

In the foregoing description and in the feature of the invention disclosed in claim, attached drawing and exemplary embodiment It can be used for individually or in any combination implementing various embodiments of the present invention.

Reference numerals list

1,201 barrels

2,202 brackets

3,203 ampoules

4,204 monomer fluids

5,205 finished ground cements

6,206 charging plungers

7,207 distribution plungers

8,208 fixing devices/bolt

9,209 fixing devices/bolt

10,210 external screw threads

11,211 internal threads

12 pipes

14,214 straight-through portions

16,216 millipore filters

18,218 filters

20,220 connection plungers

22 sealed lips

24,224 sealing elements

26,226 sealing elements

28,228 sealing elements

30,230 sealing elements

32,232 shells

34,234 distribution pipes

36,236 millipore filters

38,238 caps

40,240 foams

42 wing plates

43 extrusion equipments/barrel rifle

44 push rods

46 glasss

8,48 are relatively fixed device/bolt

50 bearings

52 fragments

54 bone cement doughs/mixture

56 triple valves

58 T-handles

59 valve seats/pipe

60 collection vessels

61 accesses

62,78 wing plates

64 hoses

66 trochars

68,268 protection pipes

70,74 Luer system adapters

72 connectors

76 hoses

80 insertion pieces

82 sleeves

84 sealing elements

86 stop parts

88 passing aways

90 vent openings

102 triple valves

103 pipes

104 hoses

109 collection vessels

112 sleeves

114 static mixers

116 valve seats

118 insertion pieces

119 accesses

120 passing aways

212 hollow needles

222 plugs

242 diaphragms.

Claims (25)

1. a kind of storage and mixing apparatus, for the monomer fluid (4,204) and cement powder by the starting ingredient as bone cement Last (5,205) production bone cement dough (54), the storage and mixing apparatus include：

Bracket (2,202) is disposed with monomer fluid container (3,203) in the bracket, wherein the monomer fluid container (3, 203) monomer fluid (4,204) is accommodated,

Barrel (1,201), the barrel accommodate the finished ground cement (5,205),

The charging plunger (6,206) being arranged in the bracket (2,202), wherein the feed column plug (6,206) can be along described The longitudinal direction of bracket (2,202) is mobile and can be reached from the back side of the bracket (2,202), and

The distribution plunger (7,207) being arranged in the barrel (1,201), wherein the distribution plunger (7,207) can be described The inside of barrel (1,201) shifts along the longitudinal direction, wherein

The bracket (2,202) front with or can be connected with the back side of the barrel (1,201) so that the bracket (2,202) Inner space and the inner space of the barrel (1,201) connect to penetrate the monomer fluid (4,204), wherein the connection It is dissoluble, and wherein

The first fixing device (8,208), the back of the body in the barrel (1,201) are provided on the back side of the bracket (2,202) The second fixing device (9,209) is provided on face, wherein first fixing device (8,208) and second fixing device (9, 209) it is identical or similar.

2. storage according to claim 1 and mixing apparatus, which is characterized in that

It is provided on the back side of the barrel (1,201), particularly in the distribution plunger (7,207) of the barrel (1,201) Lead to the closed straight-through portion (14,214) in the inner space of the barrel (1,201), wherein the closed straight-through portion (14,214) are preferably able to the connection solution of the liquid permeable between the bracket (2,202) and the barrel (1,201) Except when closed in fluid-tight manner, wherein the closed straight-through portion (14,214) particularly preferably include valve, at least two Sealed lip (22) or self-enclosed pierceable formula diaphragm (242).

3. storage according to claim 2 and mixing apparatus, which is characterized in that

Hollow needle (212) or pipe (12), the inside of the bracket (2,202) are provided on the front of the bracket (2,202) It can be connected with the inner space of the barrel (1,201) in a manner of conducting liquid the hollow needle or pipe, wherein if The bracket (2,202) and the barrel (1,201) connect, then the hollow needle (212) or the pipe (12) together with it is described can Closed straight-through portion (14,214) forms the permeable monomer liquid led in the inner space of the barrel (1,201) together The interconnecting piece of body (4,204).

4. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

Connection plunger (20,220) is disposed on the front of the bracket (2,202), the connection plunger is arranged to can be It moves along the longitudinal direction the inside of the bracket (2,202), wherein the monomer fluid container (3,203) is arranged in the company It connects between plunger (20,220) and the charging plunger (6,206), wherein be provided in the connection plunger (20,220) logical Road, the access can permeate the monomer fluid (4,204) and gas and can be used for establishing the inside with the barrel (1,201) Space fluidly connects, wherein preferably, by means of the connection plunger (20,220) towards on the direction of barrel (1,201) Movement makes and sealing on the barrel (1,201) of front connection of the bracket (2,202), the back side of the barrel (1,201) The inner space of the inner space and the bracket (2,202) of the straight-through portion (14,214) or the closing barrel (1,201) closed Between liquid permeable interconnecting piece locking device (12,212) open.

5. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

It is provided in being connected to the interconnecting piece of liquid permeable of barrel (1,201), on the front of the bracket (2,202) Sieve or the porous disc (18,218) that gas and liquid can be permeated.

6. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

The storage and mixing apparatus are storage and mixing for starting ingredient and are used in spine regions described in application The bone cement applicator of bone cement dough (54), wherein the bone cement applicator preferably include be arranged in the barrel (1, 201) the extension distribution opening on front, wherein extension distribution be open particularly preferably by distribution pipe (34,234), Hose (64,104) and/or trochar (66) are realized.

7. storage according to claim 6 and mixing apparatus, which is characterized in that

Being disposed in extension distribution opening or between extension distribution opening and the barrel (1,201) can be from outer The triple valve (56,102) of portion's operation,

The collection vessel (60,109) for receiving bone cement dough (54) is disposed on the triple valve (56,102), In, extension distribution opening converges in application opening, described applying that opening is arranged in the extension distribution opening with institute State barrel (1,201) back to end on, wherein the triple valve (56,102) is suitably designed so that it：

Fluidly connecting between the application opening and the barrel (1,201) is provided in first position and is closed described in The passing away (88,120) of collection vessel (60,109), and

Fluidly connecting between the application opening and the collection vessel (60,109) is provided in the second position and closes court To the access (61,119) of the barrel (1,201).

8. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

The bracket (2,202) includes attachment device (12,212), especially includes at least one hollow needle (212) or at least one A pipe (12) is using as attachment device (12,212), wherein the attachment device (12,212) is arranged in the bracket (2,202) Front on, the bracket (2,202) in a manner of conducting liquid through the attachment device (12,212) with or can be with the material The inner space connection of cylinder (1,201), and wherein, the bracket (2,202) is except the attachment device (12,212) It is closed in fluid-tight manner.

9. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

The monomer fluid container (3,203) be can the inside of the bracket (2,202) open glass ampule (3,203), Plastic ampoule (3,203), plastic film bag or aluminium-plastic compound bag.

10. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

First fixing device (8,208) and second fixing device (9,209) can be fixed on extrusion equipment (43), special It is not on the single holder (48) of barrel rifle.

11. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

The sectional area of the inner space of the barrel (1,201) is most 4cm², preferably up to 2.5cm², particularly preferably most More 1.2cm²。

12. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

The barrel (1,201) is closed by barrel head on front, wherein there is exit opening in the barrel head, it is described Exit opening by closure member (36,236) close, the closure member cannot by the barrel (1,201) finished ground cement (5, 205) it permeates and can be permeated by gas, especially millipore filter (36,236), wherein the closure member (36,236) is preferred Ground can be opened by axial compressive force load or by the effect of manual force.

13. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

The bracket (2,202) is closed by the charging plunger (6,206) or can be on the back side in fluid-tight manner on the back side It is closed in fluid-tight manner by the charging plunger, preferably with liquid-tight and air tight manner closing or can be with liquid-tight and air tight manner Closing.

14. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

The barrel (1,201) is in hollow circle tube, and second fixing device (9,209) is arranged to and extrusion equipment (43) it connects, wherein close the front of the barrel (1,201) of the hollow circle tube in barrel head, wherein in the barrel head Be disposed with exit opening in portion, and the wherein described exit opening by the outside on the barrel head in a manner of permeable gas It being connect with the inside on the barrel head, wherein distribution pipe (34,234) is connect with the exit opening on the barrel head, In, it is provided with the penetrable septum (242) at the back side that the distribution plunger is closed in a manner of impermeable liquid, and

The bracket (2,202) is in hollow circle tube, wherein in the connection plunger (20,220) in the bracket (2,202) The porous disc (18,218) of gas and liquid can be permeated by being provided with, and connection plunger (20,220) front on be disposed with to A few hollow needle (212), at least one hollow needle (212) by channel in a manner of liquid permeable with it is described porous The back side of disk (18,218) connects.

15. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

The volume of monomer fluid (4,204) in the monomer fluid container (3,203) at least in the barrel (1,201) The volume of air-filled clefts between finished ground cement particle is equally big, preferably at least empty with the inside of the barrel (1,201) Between fluid pipeline (12,14,16,18,212,214,216,218) between the inner space of the bracket (2,202) volume In addition the volume of the air-filled clefts between finished ground cement particle in the barrel (1,201) is equally big.

16. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

At least one vent openings (90) are disposed in the wall of the bracket (2,202), wherein the vent openings (90) will Inner space-monomer fluid the container (3,203) of the bracket (2,202) is arranged in the inner space-with it is described Storage is connected with the ambient enviroment of mixing apparatus, wherein at least one vent openings (90) preferably sufficiently close proximity cloth It sets in the region of the charging plunger (6,206) so that it passes through the feed column in the monomer fluid container (3,203) Before the movement unlatching of plug (6,206) by the charging plunger (6,26) on the positive direction of the bracket (2,202) Movement close.

17. storage according to any one of the preceding claims and mixing apparatus, which is characterized in that

The barrel (1,201) have 10 Palestine and Israels on, the compressive resistance in preferably 50 Palestine and Israels, in particularly preferably 70 Palestine and Israels.

18. one kind is for producing bone cement dough (54), particularly pasta PMMA bone cement dough (54) Method, wherein the bone cement dough (54) is using storage and mixing apparatus by finished ground cement (5,205) and monomer fluid (4,204) are made, wherein the storage and mixing apparatus include bracket (2,202) and barrel (1,201), which accommodates tool There are the monomer fluid container (3,203) of the monomer fluid (4,204), the barrel to accommodate the finished ground cement (5,205), In, which is fixed on or can be fixed on the back side of the barrel (1,201), the method be characterized in that with Lower the step of carrying out in succession：

A) storage and mixing apparatus are inserted into extrusion equipment (43), wherein the extrusion equipment (43) includes can be along axis The push rod (44) promoted to direction；

B) charging plunger (6,206), the feed column are promoted towards the direction of the barrel (1,201) by the push rod (44) Plug is supported on the back side of the bracket with movable manner in the bracket (2,202), wherein the charging plunger (6, 206) movement opens the monomer fluid container (3,203) and by the monomer fluid (4,204) from the monomer fluid Container (3,203) is pressed into the barrel (1,201), wherein the cement powder described in the inner space of the barrel (1,201) Last (5,205) are mixed with the monomer fluid (4,204)；

C) bracket (2,202) and the barrel (1,201) are detached, wherein the barrel (1,201) keeps in described It reinserts in extrusion equipment (43) or after releasing in the extrusion equipment (43)；

D) distribution plunger (7,207) is promoted towards the positive direction of the barrel (1,201) by the push rod (44), it is described Distribution plunger is supported in movable manner on the back side of the barrel (1,201) in the barrel, wherein the distribution column The movement for filling in (7,207) will be by the mixture that the finished ground cement (5,205) and the monomer fluid (4,204) form with bone water The form of mud dough (54) is discharged from the barrel (1,201).

19. according to the method for claim 18, which is characterized in that

Using according to any one of claim 1 to 17 storage and mixing apparatus implement this method.

20. the method according to claim 18 or 19, which is characterized in that

Closed straight-through portion (14,214), the monomer fluid (4,204) are provided on the back side of the barrel (1,201) The inside of the barrel (1,201) is pressed into through the straight-through portion in step b), wherein the closed straight-through portion (14, 214) it is closed when the bracket (2,202) and the barrel (1,201) detach in step c) or during the separation voluntarily Closing.

21. the method according to any one of claim 18 to 20, which is characterized in that

The first fixing device (8,208) is provided on the back side of the bracket (2,202), and in the barrel (1,201) The back side on be provided with the second fixing device (9,209), wherein it is described storage and insertion phase of the mixing apparatus in step a) Between, the storage is fixed on the holder of the extrusion equipment (43) with mixing apparatus by first fixing device (8,208) (48) on, and the barrel (1,201) is fixed on the extrusion in step c) by second fixing device (9,209) On the holder (48) of equipment (43).

22. the method according to any one of claim 18 to 21, which is characterized in that

Connection plunger (20,220) is disposed on the front of the bracket (2,202), wherein the monomer fluid container (3, 203) it is arranged between the connection plunger (20,220) and the charging plunger (6,206), wherein in step b), in institute It states while charging plunger (6,206) is pushed into and is pressed into the barrel (1,201) in the monomer fluid (4,204) Forward position described in the direction of barrel (1,201) drive the connection plunger (20,220), wherein lead to the barrel (1,201) In access therefore open so that the inner space of the barrel (1,201) and the inner space of the bracket (2,202) are with can The mode of permeation liquid is connected to each other between the charging plunger (6,206) and the connection plunger (20,220), wherein excellent Subsequently or simultaneously, the monomer fluid container (3,203) is by the charging plunger (6,206) towards the connection plunger for selection of land The movement of (20,220) and opened, the plastics or glass ampule (3,203) especially as monomer fluid container (3,203) exist It is crushed between the charging plunger (6,206) and the connection plunger (20,220) so that can be in the bracket (2,202) The monomer fluid (4,204) being pressed into the barrel (1,201) is obtained in inner space.

23. the method according to any one of claim 18 to 22, which is characterized in that

The mixture of finished ground cement (5,205) and monomer fluid (4,204) described in step d) is by from the barrel (1,201) It extrudes and is forced through extension distribution opening, distribution pipe (34,234), hose (64,104), trochar (66) and/or static state and mix Clutch (114), wherein the bone cement dough (54) generates in the barrel (1,201) wherein or before this.

24. the method according to any one of claim 18 to 23, which is characterized in that

Have can be from the triple valve of peripheral operation in extension distribution opening or in the arranged downstream of the barrel (1,201) (56,102), wherein the triple valve (56,102) is placed in first position or is in the first position, wherein described three Port valve (56,102) is provided when in the first position and is distributed from the inner space of the barrel (1,201) through the extension What is be open is continuously coupled, and the extrusion by the extrusion equipment (43) of the barrel occurs in step d), wherein by The bone cement dough (54) that the finished ground cement (5,205) and the monomer fluid (4,204) mix is squeezed through institute It states triple valve (56,102) and is distributed by the extension and is open, subsequent generation step e), the threeway described in step e) Valve (56,102) transforms to the second position, wherein the triple valve (56,102) makes when in the second position from described Barrel (1,201) is stopped by the flowing of the triple valve (56,102), in the triple valve in extension distribution opening A part for the bone cement dough (54) under pressure in (56,102) downstream is pressed into receipts through the triple valve (56,102) Collect in container (60,109).

25. according to the method for claim 24, which is characterized in that

The triple valve (56,102) is moved to the first position in the step f) after step e), and passes through this side Formula, the bone cement dough (54) is open through the distribution passes through the triple valve (56,102) by guiding again, wherein preferably Next it is sequentially repeated step d), e) and f) one or many.